MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00028-120

Device Problems Crack (1135); Device Issue (2379); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that during a spinal fusion procedure, the imaging system door wouldn't open after taking a 3d spin.To troubleshoot the issue the site radiologic technologist (rt) attempted to manually open the door but the door would not open.The system was rebooted with no change, the site opted to reboot the system again which returned the door to normal function.The surgeon opted to continue the procedure with the use of the imaging system.Later in the procedure, after a spin with the imaging system, the door again would not open.After 2 more reboots of the imaging system, the door opened and functioned normally.The rt was able to open and close the door several times using the pendant/button.The surgeon completed the procedure with the use of the imaging system.It was reported this issue caused an hour delay to the procedure.There was no known impact on patient outcome.

Manufacturer Narrative

A medtronic representative performed a imaging system check-out and reported the system functioned as expected during testing.The medtronic representative reported the system passed all testing.The door covers were found undamaged and the reported issue could not be duplicated.No further issues reported.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4742920
• MDR Text Key: 5883661
• Report Number: 1723170-2015-00540
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: BI-700-00028-120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 98